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Merck, Bristol-Myers immunotherapies impress in key lung cancer trials


By Bill Berkrot

(Reuters) - Merck & Co's Keytruda plus significantly improved overall survival versus alone in newly-diagnosed patients with advanced non-small cell lung in a highly-anticipated study that appears to cement the company's lead in the most lucrative market.

While magnitude of the survival benefit in the late-stage study was not yet known, the Keytruda combination cut the risk of death by 51 percent compared with and significantly delayed worsening, according to data presented on Monday.

"This study showed a clear difference in long-term outcomes," said Dr. Leena Gandhi, the study's primary investigator, who called the results "practice changing."

In another closely-watched study, a combination of drugs and significantly stalled progression versus standard chemotherapy in newly-diagnosed advanced non-small cell lung (NSCLC) for patients whose had a high number of genetic mutations. (TMB) is a potentially important new biomarker for identifying those most likely to benefit from

The results were presented at the American Association of Research meeting in

Keytruda and have piled up approvals for advanced cancers, such as for and But those drugs and rival from and are jockeying for pieces of the largest market. Thus far, Merck is dominating the coveted newly-diagnosed setting.

There are more than 200,000 new cases of each year in the alone, with about half at advanced stage at the time of initial diagnosis.

The Keytruda plus chemotherapy regimen was approved as an initial, or first-line, treatment for advanced patients based on earlier data from a small study. But many clinicians wanted to see validation of a survival benefit in a large trial.

"We were all waiting to see a definitive Phase III study that showed very clear cut results," said Gandhi, director of thoracic medical at Langone in

In both studies, the positive results were not dependent on cancer cell's levels of PD-L1, a marker of that has been commonly used with drugs like Keytruda and to help predict patient responses, with higher PD-L1 levels believed to lead to greater efficacy.

In the Merck-sponsored trial called Keynote-189, median overall survival was 11.3 months for chemotherapy but not yet reached for the Keytruda combination. "We don't know how long their survival is going to be and we're excited about that," Gandhi said.

After 12 months, 69.2 percent of patients in the Keytruda group were alive compared with 49.4 percent for chemotherapy, researchers reported.

The differences would likely have been more pronounced, but many patients in the chemotherapy group were given Keytruda or a similar drug once their progressed.

In the study called CheckMate-227, 43 percent of patients with high TMB who received Opdivo and low-dose experienced no disease progression after one year versus 13 percent in the chemotherapy group. There was preliminary evidence of a likely survival benefit but it was too early to determine that, researchers said.

The overall response rate - those with shrinkage - was 45 percent for the versus 27 percent for chemotherapy. After one year, 68 percent of responders to Opdivo and continued to benefit from the therapy.

Dr. of in New York, who led the study, said it was a validation of TMB as a biomarker and that Opdivo with Yervoy should be an important chemotherapy-sparing regimen in first-line

"This is great that there's new options and improved outcomes," Hellman said of the two studies. "That's tremendous progress for patients with "

(Reporting by Bill Berkrot; editing by Diane Craft)

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, April 16 2018. 19:16 IST